Composition containing at least one nutrivite, at least one disinfecting or decontaminating, and/or at least one protease-inhibiting active compound and/or active compound complex

ABSTRACT

The present invention relates to a composition containing at least one nutritive, at least one disinfecting or decontaminating and/or at least one protease-inhibiting active compound and/or active compound complex for the external care and/or treatment of wounds of the human or animal body.

The present invention is comprised of a composition for external careand/or treatment of wounds in accordance with the concept of claim 1.

STATE OF TECHNOLOGY

Many animal and human wounds, particularly chronic, i.e. wounds lastingseveral weeks, or wounds with fistulas, typically heal more slowly. Mostrequire a replacement of lost tissue with renewable tissue from theaffected area. A characteristic of such wounds is the development ofpathological exudates, which damage and delay the healing process. Suchwounds are particularly prevalent in the extremities (particularly thevenous ulcer), in the back (decubitus), but also in the oral region(dental and jaw surgery wounds).

Regarding the inhibitory effects, which result from the pathologicalexudate in the wound, thereby extending the chronification process, theremoval of the pathological exudate is necessary for the wound to heal.The state of technology describes dressings containing super-absorbentparticles or PU foams which have a high absorbency capacity. Theseremove the exudate from the wound, and restrain such. Due to the highlevel of suction, the exudate is not only absorbed from the surface ofthe wound, but also from the depths of the wound. In this manner, theaffected area and surrounding region is better protected from activedamage due to proteases. Such dressings are familiar to the applicant ofthe present invention from, for example, the WO03094813.

Due to their high absorbency capacity, these dressings may remain on thewound for longer, i.e. several days, periods of time. The resting periodof the wound is significantly extended, and bothersome and painfuldressing changes are thereby reduced. This contributes to an improvementof the wound situation, in that through the reduced dressing changingfrequency, the cooling of the wound as well as the risk of infection andthe danger of secondary trauma are decreased.

The long resting period may however lead to septic processes, as thewound is cleaned and/or disinfected less frequently. Particularly incertain cases, one must expect microorganisms in the dressing toreproduce, and thereby result in a secondary re-infection of the wound.

In addition, particularly chronic wounds suffer from nutrient deficits,which significantly slow down and influence the healing process.

These problems specified particularly for chronic wounds have as yet notbeen addressed by the dressings.

DISCLOSURE OF THE INVENTION

The task of the present invention is therefore, to provide acomposition, which makes it possible to confront the septic processes inchronic wounds having moderate to strong exudation.

A further task is to provide a composition which enables the promotionof the healing process for chronic wounds having moderate to strongexudation.

A further task is to provide a dressing which may be applied for alonger period of time to a wound, without the risk of said applicationresulting in a septic process.

A further task is to provide a composition which reduces the activity ofhealing inhibiting proteases.

These tasks are solved through the characteristics of the present set ofclaims. The subsidiary claims provide preferred design versions. Itshould be noted thereby that the specified range specifications are tobe understood consistently, including the respective limit values.

In accordance with this, a composition is intended which contains atleast one nutritional and/or at least one disinfecting agent and/orcomplex of agents for external care and/or treatment of wounds to humanor animal bodies.

The term “complex of agents” should not be understood in the followingas a complex in the chemical sense, but rather, particularly, as asynergistic composition of effective agents.

In the publications, the relationships between the nutritional conditionof the patient and the healing have already been described (Arnold M.,Barbul A. (200), “Nutrition and wound healing”, Plast. Reconstr. Surg.117(7 Suppl.): pages 42-58). Similarly, it has been indicated that byimproving the nutritional condition of a patient, the healing processmay be improved (Patten J. A. (1995) “Nutrition and wound healing”,Compend. Contin. Educ. Dent. 16(2):200, 202-4, 206-8). However, themethods described in the publications as a means of treating thisdeficit, a systemic approach is always recommended, i.e. compensationfor the deficit by improving the nutritional situation. Topicalapproaches in this regard have not yet been described in the availableliterature.

The reasons for this are that the experts avoid, in general, a so-called“off label use”, i.e. the use on a wound of familiar, or even agentswhich appear to be trivial, not having a familiar indication for use. Inaddition, there are major legal problems regarding this.

Furthermore, according to the prevalent school of thought, a woundshould be treated with as few as possible, and with precisely defined,means. The experts, however, are opposed to the use of complexes and, ifthe case may be, less defined compositions being used in the treatmentof wounds.

In addition there is the aspect, that agents for improving thenutritional condition of a patient that may be taken orally are notnecessarily suitable for topical treatment, as they may cause allergicand/or immunity reactions, or respectively, infectious processes. As aresult, only hypoallergenic, non-pyrogenic, and, as the case may be,sterile ingredients, may be used, which are naturally much moreexpensive to produce.

A wound treatment article for treating local pain in a wound is known offrom the WO03055536, which contains a composition with a means forabsorption of exudates from wounds as well as a pain reliever, wherebythe composition is a means of inhibiting infections and relieving pain.

A product with these characteristics, having with the brand name“Biatain—Ibu” from the company Coloplast, is also available. With thisapplication, or respectively, this product, the pain relief aspect isthe primary focus, however, and not the promotion of the healingprocess, which is significantly more complex than pain relief.

Furthermore, in accordance with the invention, the use of one or morecompositions of this sort is intended for the production of a means forexternal, non-systemic topical caring for and/or treating of wounds tohuman or animal bodies.

Particularly preferred thereby, it is intended that the dosage form ofthe, at least one, agent or complex of agents be selected such that itresults in only a topical, non-systemic effect.

In the following, the term “non-systemic” should be understood to meanthat the, at least one, agent has only a local and/or topical effect tothe affected area.

This can be accomplished for example, through a suitable determinationof the concentration and/or dosage of the, at least one, agent. Thiswill be explained more precisely later in this text.

Furthermore, it is intended preferably, that the, at least one, agent orcomplex of agents be available in a form, such that when applieddirectly or indirectly to the wound said agent may migrate into thewound and/or cells in the surrounding region. It is intended that therebe a gradual, step-by-step application of the healing agents over thecourse of the application with a reduction of the concentration anddosage of said agents in the dressing to the affected area.

Furthermore, it is intended in one design version that at least oneagent or complex of agents be provided in a form, which allows foradmission of said through the cells of the affected area.

The term “direct application” should be understood to mean that thecomposition is applied to the wound directly in the form, as the casemay be, of a powder, a fluid, a paste, or a gel.

The term “indirect application” should be understood to mean however,that the composition is contained, for example, in a dressing or anothermedium, and said dressing or other medium is then applied to the wound.

In the following, the term “migration” should be understood to refer topassive and active transportation processes, which affect an applicationof the, at least one, agent or complex of agents in the wound. Theseare, particularly, diffusion processes, but also active transportationprocesses as well as mechanical effects to, as the case may be, apresent dressing, which result in the movement of a fluid from thedressing into the wound.

Exudate is a wound fluid derived from plasma through the infectionprocess of the wound edema. Just as the blood is responsible for thetransportation of nutrition and other substances to be supplied tovarious parts of the body, in a similar manner, the exudate serves as ameans of caring for the affected area, and the healing cycle. In orderto fulfill these many functions, it contains a wide range of components,which, as a result has a specific mass which is slightly higher thanthat of water. In this manner, it differs from transudate, which is theresult of non-infectious processes, and has a significantly lowerspecific mass, with a lower cell and protein content. Aside fromproviding nutrition to fibroblasts and epithelial cells, the exudatecoordinates the various processes of the healing process both temporallyand spatially through its high content of growth factors and cytokines.These are comprised primarily of platelets, keratinocytes, macrophagesand fibroblasts. They influence the motility, migration andproliferation of the various cells involved in the healing process. Inthis manner, the immigration of cells to the affected area is promotedjust as much as the care for the newly developed granular tissue as aresult of angiogenesis. The cleansing of the wound is also supported bythe exudate. It contains various serine, cysteine, and asparticproteases as well as matrix metalloproteinases, which are active in theremoval of irreversibly damaged tissue and thereby prepare the affectedarea for the subsequent phases of the healing process.

Components of the physiological exudate are, particularly, salt,glucose, cytokines and growth factors, plasma proteins, proteases(particularly matrix metalloproteinases), granulocytes and macrophages.

If there is not significant progress in the healing process within a fewweeks, in regard to the various phases of the healing process, then onerefers to this as a chronic wound. In this case, one observes longerexudative phases as complications, and refers to this as pathologicalexudation, which may contribute to a chronification of the wound. Theunderlying causes are for the most part complex and my also be of asystemic nature. It is, however, not surprising that based on thepreviously explained importance of the exudate for the healing process,that complications in the healing process are reflected by asignificantly altered composition and effect of the exudate. Amongothers, through a shift in the concentration of the individualcomponents of the exudate, the exudate loses its positive effect ofnormally promoting healing in the case of chronic wounds. In particular,the content of inflammatory cytokines and proteases is significantlyincreased in pathological exudates. The content of growth factors,however, is decreased.

A particularly serious difference occurs in regard to the activity ofthe previously referred to proteases. Aside from the preparation of theaffected area, they are also involved in the later conversion ofgranular tissue to scar tissue. These enzymes are normally formed as aninactive pre-enzyme, and its activation is regulated by respectiveinhibitors (“tissue inhibitors of metalloproteinases, TIMPs”), which atthe same time have a positive affect on cell growth. In chronic exudateit would seem that, due to disturbances in the regulatory system, theactivity of the proteases is increased, which contributes to activeregression of the wound.

The terminology “nutritional substance, or respectively, complex ofsubstances” should be understood in the following to mean macro andmicro nutrients, particularly minerals, trace elements, vitamins,pro-vitamins, vitamin derivatives, proteins, proteinogenic andnon-proteinogenic amino acids, carbohydrates, particularly starch,glucose and fructose, fats, fatty acids and fatty substances(particularly mono- and diglyceride, phospholipids, lipids, cholesterol,squalene, carotene), organic acids, nucleic acids and/or primary orsecondary vegetable material.

The term “disinfecting substance or complex of substances” should beunderstood in the following to mean antiseptic, antibiotic,bacteriostatic, antiviral, and/or antimycotic substances. For this, itmay be seen that the antiseptic, antibiotic, bacteriostatic, antiviraland/or antimycotic effect only refers to certain representatives of therespective class of organism (bacteria, virus and/or fungus),particularly pathogenic representatives, while other representatives,particularly non-pathogenic representatives, are not meant.

The term “decontaminating substance or complex of substances” should beunderstood to mean, in the following, substances that serve asdecontaminants. Decontamination has the purpose of removing potentiallydamaging substances from the surface area. The decontamination issuccessful when the particles are removed from the surface area and canbe appropriately disposed of For the decontamination of a chronic wound,there exists only a very limited range of possibilities. Requirementsfor the decontamination of a chronic wound consist of, for one, theremoval of cell detritus, dried secretions, and if the case may be, deadtissue (necroses). Furthermore, in the framework of decontamination,micro-organisms, as a rule bacteria, sitting on and within the tissuesare removed. The aim of the decontamination is to keep the bacterialcount and the contamination of the wound so low that the natural healingprocess is not inhibited.

The background for this approach—in contrary to what was said at thebeginning—is not necessarily chronic wounds, but also acute traumata,such as may be observed, for example, in military operations, resulting,for example, from irradiation, burning or the influence of biologicalweapons. Particularly with biological weapons, the decontaminationcharacteristics are of primary importance. In addition, there is thefact that the super-absorbent polymers, which will be described later,can absorb and immobilize micro-organisms, particularly those frombiological weapons. A dressing containing disinfecting substances aswell as super-absorbent polymers can therefore be used in the first aidof a biologically contaminated individual, in particular, a soldier. Itmust be properly disposed of after use—i.e. autoclaved, as a rule.

With burning and irradiation, which also are often observed inconnection with military conflicts, tissue necrosis occurs, which may besuperficial to some extent, and to some extent however is embedded deepin the tissue, and can make its way to the surface through fistulas.Wounds of this sort are extremely susceptible to infection. For this, adressing containing a disinfecting composition as well assuper-absorbent polymers can also be extremely useful. In addition, inthat such a dressing is capable of this, necrotic components as well as,if the case may be, irradiated particles—particularly those making theirway to the surface through fistulas—may be removed from the affectedarea, and restrained. A dressing of this sort must also be properlydisposed of.

The decontaminating effect can be affected or increased through theapplication of necrolytic and/or exudation forming components, as willbe described later. The promotion of the necrolysis facilitates therebythe deconstruction and removal of contaminated components, while thepromotion of the exudation facilitates the cleansing and thereby thedecontamination.

The term “proteases inhibiting substance, or complex of substances”should be understood in the following to refer to such substances thathave an inhibiting effect on proteases in the affected area,particularly matrix metalloproteinases. These may be, particularly,acidifying substances or complexes of substances, as well as proteaseinhibitors, super-absorbent polymers, chelators for divalent cations,collagen, or coated magnetic particles.

The term “acidifying substance or complex of substances” should beunderstood in the following to mean such substances as those having anacidifying effect to the wound, i.e. lowering the pH value in the wound.This can be useful in inhibiting the damaging proteases in certainphases, as is described above, which are normally active in the neutralto alkaline region. “Acidifying substances or complexes of substances”may therefore refer to, for example, acids, and particularly organicacids. Furthermore, these can be non-pathogenic, acid producingbacteria, particularly lactic acid bacteria, prebiotics, i.e. such acidproducing bacteria that are a part of a selective nutritional substratewhich can be metabolized, or are symbiotic (see below).

The substances or complexes of substances are preferably water soluble,as previously mentioned. This means in particular as well, that they arepreferably soluble in exudate.

A stronger wound exudation results in a higher dissolving rate, based onthe above mentioned solubility, and thereby, a larger quantity ofsubstance delivered to the wound. This is particularly beneficial ifthere are several wounds, whereby the necessity for treatment increasesin proportion to the degree of pathological exudate. In this case, aself regulating mechanism is initiated, as a result of the design of theinvention, whereby the wound “self extracts” the amount of substanceneeded according to its degree of exudation, in the sense of the abovedefinition.

It can thereby be intended that a light exudation first results in thecomposition assuming the function of absorbing exudate, which may bebeneficial for the time being. If, over time, the exudation increases,the components of the composition are released, and are transported tothe affected area of the wound by the reflux (sustained-release effect).

In another design, it may be intended that the substances or complexesof substances at least partially are in a fat-soluble form. This may bebeneficial if fatty or non-polar mediums are used, such as, for example,Vaseline, the petroleum based blistering compound, or a fat-gauze.

Furthermore, in accordance with the invention, it is intended that the,at least one, substance or complex of substances be introduced to awater soluble matrix. Such a matrix can, for example, have the form ofwater soluble sheets. If this matrix is applied to the wound, itdissolves without a trace, and the substances or complexes of substancesare able to take effect. Suitable materials for such a sheet, or,respectively, such a matrix are, for example, polysaccharides, such asmodified (i.e. water soluble) starches, using an unloading structure, orgelatin.

Particularly preferably, it is intended that the, at least one,substance or complex of substances, be incorporated in a planar pad.

This pad may be, for example, an alginate mat, a pad or layer ofcarboxymethyl cellulose, air-laid, fleece, PU, silk or cellulose. Inparticular, it may also be a wet wipe, which is impregnated with asolution containing the composition of the invention. In this design, anadditional dressing is normally necessary, which is used to keep the padin place on the wound. A dressing of this sort is described, forexample, in the DE102007019622 by the applicant, the disclosure contentof which is to be added in full to the disclosure content of the presentinvention.

This dressing can be, for example, a dressing for absorbing exudatesfrom wounds, as the applicant's DE10059439 as well as WO03094813describes for the present invention, the contents of which are to beadded in full to the disclosure content of the present invention. Thesize of the pad may correspond basically to the area of the wound, inorder to provide the wound with the said substances or complexes ofsubstances as homogenously as possible.

Alginate (or alginic acid, E400) is formed in the cell walls by brownalgae, and places the structuring element in the alga. Alginate is usedprimarily as a thickening or gelling agent. The gelling is a result ofstoring calcium ions, from which three-dimensional structures areformed. Although this reaction with calcium takes place quite quickly,in practice various methods are used in order to control the rate of thereaction. For this, poorly soluble calcium salts are used, whichgradually release the calcium through slow acidification. Furthermore,sequestrants may also be used, which can bond to a portion of thecalcium.

The specified substances or complexes of substances may preferably beapplied to a pad of alginate. The light, minimal swelling of alginateallows for a particularly good adaptation to the affected area with aparticularly high application and contact surface on the surface of thewound, such that in this case a particularly intensive exchange ofnutrients is able to take place in the affected area. The alginate pad,or respectively, another material compatible with the wound may have ameandering, labyrinthine, spiral or radial incision, which allows for aneasier application to the affected area.

Carboxymethyl cellulose (CMC) is a cellulose derivative, whereby aportion of the hydroxyl groups of the cellulose is combined as etherwith a CH₂—COOH-(carboxymethyl-) group. For the production, thecellulose is transferred to reactive alkaline cellulose and subsequentlyconverted to carboxymethyl cellulose with chloroacetic acid. Thecellulose structure remains intact. CMC is insoluble in water in itsacidic form. It is however relatively water soluble in alkaline states.

Mats of carboxymethyl cellulose provide for a good adaptation to theaffected area and show a high affinity to water; therefore, thepotential for introducing other substances into the CMC pad throughwater is to be emphasized. In this manner, substances or complexes ofsubstances which are to be released to the surface of the wound,particularly in the case of over-saturation with exudate, can be washedout of the pad, and thereby made available.

PU pads are foam dressings of polyurethane, having the characteristic ofbeing able to absorb water using the principle of capillary forces, andthereby expand. When these contain the said substances or complexes ofsubstances, the low retention force of the foam when moistened withexudate, for example, leads to a rinsing of the substances or complexesof substances in the wound.

Fleece is a textile material, which in contrast to textiles made ofyarns, consists of single, non-woven fibers. Fleece differs from papergenerally in the length of the fibers, which are much shorter in said.Fleeces generally absorb liquids quite well.

Frequently, the specified materials are produced as air-laids. Thisprocess results in very smooth and absorbent products, frequently havinga three-dimensional surface which is ideal for use with the compositionof the invention.

The composition of the invention can ideally be presented in the formwhereby it is applied to a medium of silk and/or hydro-fibers and/orincorporated in an impregnated bandage, embedded in colloid, embedded insilicone, embedded in CMC, embedded in polyester film and/or embedded inpolyethylene film.

Silk is a fine textile fiber extracted from the cocoon of the silk worm,the larvae of the silk spider. Due to its hygroscopic characteristics innon-woven layers, the release of the substances into the affected areais improved.

Hydro-fibers are produced from sodium CMC and polyester fibers and cancontain large quantities of liquids. The liquid is absorbed into thefibers and spreads very little horizontally, and thus the danger ofmaceration is quite minimal. A moist, warm healing promoting environmentis formed beneath the dressing. It is ideal, in combination with thecomposition of the invention, for exudate management and the promotionof granulation.

Impregnated gauze is gauze that is impregnated with a substance such asVaseline, wax or oil in order to inhibit the sticking of the gauze tothe affected area.

Moreover, the coating is suited to storing fat-soluble substances and/orcomplexes of substances in accordance with the invention. These aresuccessively released upon contact with the affected area, andtransferred to the wound.

A colloid is a system comprised of clusters or small solid bodies thatare finely distributed within a medium. The particles of this so-calledcolloid dispersion phase are generally 1-1,000 nm in at least onedimension. The medium itself is referred to as a dispersion medium. Thefield of chemistry which is concerned with colloids is called colloidchemistry. Dispersions comprise one category of one fluid in anotherfluid, in that the two can not mix. Examples of these so-calledemulsions are to be found in cosmetics. When dealing with more than twosubstances, so-called multiple colloids, one refers to multipleemulsions.

Colloids have an enormous internal surface area, which is highlybeneficial, particularly with substances that are activated on contact(as is the case, for example, with anti-bacterial functioning colloidalsilver ions). The technologies for producing such colloids are in thefield of nanotechnology.

Silicone is a term for a group of synthetic polymers, whereby siliconatoms are coupled by oxygen into molecule chains and/or networks. Theexcess free valence electrons of the silicon are saturated byhydrocarbon radicals (for the most part methyl groups). As a rule,silicones are physiologically compatible (not harmful), and for thisreason are used for skin protection, cosmetic skin care and plasticsurgery.

Polyesters (PE) are polymers with ester bonds —[CO—O—]—in their mainchains. They may be used within the framework of the present inventionas inert mediums without retention force to the substances and/orcomplexes of substances.

Polyethylene (PET) is a thermoplastic synthetic produced by thepolymerization of ethane [CH2═CH2]. Films of PET may be used within theframework of the present invention as inert mediums without retentionforce to the substances and/or complexes of substances. For thispurpose, other thermoplastic synthetics, such as polyester or polyamide,may also be suited.

In another preferred design, it is intended that the, at least one,substance or complex of substances, is integrated in a protectivedressing.

A protective dressing is in direct contact to a wound, and prevents asecondary dressing (e.g. a dressing containing super-absorbers) appliedto the protective dressing, from sticking to the wound. A protectivedressing of this sort—not, however, having the composition of theinvention—is known of, for example, under the brand name “Sorbion Plus.”The advantage of this design is that the protective dressing is indirect contact with the wound, and the substances of the composition cantherefore be brought into direct contact with the affected area, therebyavoiding long diffusion paths. Further advantageous designs of aprotective dressing of this type are for example, gauzes containingoils, (lipo-) colloids, silicone, or carboxymethyl cellulose. Aprotective dressing of this type is already known of from theDE102006017194 by the applicant, the disclosure content of which is tobe added in full to the disclosure content of the present invention.This consists of a film made of thermoplastics, having severalthree-dimensional perforations, the sides of which are, for the firstsurface, smooth, in each case beginning with an overlapping borderhaving a free edge, and the second surface of which is rough and easilygrasped. This protective dressing has cavities on one side, in which thesubstances of the composition can be placed in advance, and therebyapplied directly to the affected area.

Furthermore, it may be intended that the, at least one, substance orcomplex of substances be incorporated in an absorbing dressing having atleast one active element, selected from the group containing: a foampad, an air-laid, a carboxymethyl cellulose pad, an alginate pad and/ora pad containing super-absorbing particles.

The specified foam pad may be, for example, a pad of polyurethane foam.

Super-absorbing particles (also called super-absorbent polymers) aresynthetics which are able to absorb many times their weight in fluid.The product comes in the form of a white, coarse powder having particlesizes ranging from 100-1,000 μm (=0.1-1.0 mm). It is found, for the mostpart, in diapers, but also in products for feminine hygiene andincontinence hygiene. As a rule, super-absorbents are chemicallycomprised of copolymers of acrylic acid (propenoic acid, C₃H₄O₂) andsodium acrylate (sodium salt of the acrylic acid, NaC₃H₃O₂), whereby theproportions of the two monomers may vary with regard to each other. Inaddition, a so-called core cross linker (CXL) of the monomer solution isadded, which binds in places the long-chain polymer molecules which areproduced to each other with chemical bridges (they are “netted”).

This dressing ideally contains 10-60% by mass of this super-absorber(SAP). It is preferably designed such that it contains no binder. Forthis, ideally it is intended that the core of the dressing is comprisedof cut cellulose fibers, or, respectively, layers, which are in contactwith the SAP particles at a slant, and in this manner stabilizes thedressing.

Ideally, this dressing has two cellulose pads on both sides of thiscore, as well as, as the case may be, a sheath made of material thatallows fluid to pass through it.

A dressing which contains super-absorbent particles is described in, forexample, the DE10059439 or in the EP1507498 by the applicant of thepresent invention, the contents of which are to be added in full to thedisclosure contents of the present invention.

A dressing of this sort is an absorption body to be applied to the humanbody, in particular for absorbing fluids which are secreted from partsof the human body, such as wounds. These absorption bodies are comprisedof a, for the most part, flat piece of material made of absorbentmaterial, comprised of an absorbing fleece containing a dispersion ofsuper-absorbing particles, and a sheath made of a material which allowsfluid to flow through, which contains the piece of material and createsa barrier against solid excretions, and allows the passage of othersecreted substances to the absorptent material located within thesheath. A dressing of this type is available, for example, from thecompany Sorbion, of Germany, under the brand name “sorbion sachet”.

It is particularly suited to hydroactive therapy of chronic wounds, inwhich harmful exudate, including the harmful components containedtherein (particularly pathogens and proteases), are absorbed andcontained by the super-absorbers, while simultaneously generating ahealing promoting moist environment. In addition, dressings of thissort, due to their high absorption capacity, may remain on the wound forlonger periods of time, thereby preventing traumata associated withfrequent changes of the dressing. The specified dressings have been verysuccessful in the treatment of chronic wounds exhibiting strongexudation.

The previously mentioned dressings may also be designed such that theactual absorbing material is available in the form of a powder,granulate, flakes, beads, or shreds. In this manner, the contact regionbetween the exudate and the absorbing material is enlarged, and theabsorption of exudate, as well as the release of the substances orcomplexes of substances of the composition of the invention to the woundis thereby accelerated.

Furthermore, the dressing, of any pad or particle components, may beconcave in shape.

Particularly preferred is a design whereby the, at least one, substanceor complex of substances is incorporated in a dressing containingsuper-absorbent particles as well as at least one foam pad and/orcarboxymethyl cellulose pad.

A dressing in various forms of this configuration is described, forexample, in the application WO2007051599 by the applicant of the presentinvention, the contents of which is to be added in full to the contentsof the disclosure of the present invention. The same applies to theDE20200601682 by the applicant of the present invention.

In addition, the combination of a dressing containing super-absorbentpolymers and a composition in accordance with the invention with avacuum drainage device is also intended. Dressings of this sort—as yetwithout the composition of the invention—are familiar to the applicantof the present invention from, in particular, the patent applicationsWO200604240 and WO2006056294.

With dressings of this sort, whereby as a rule they are applied to thewound in a manner such that they are airtight, and attached to a vacuumpump, the drainage effect is of fundamental importance. However, thevacuum pump does not run continuously, but, rather, is turned offperiodically. In these phases, the healing promoting effect of thecomposition of the invention could become significant.

In this manner, a sandwich construction, for example, of a cellulose padcontaining super-absorbent particles with high absorption capacities, aswell as a foam pad with relatively limited absorption capacities, can becreated. A dressing of this sort allows for the accommodation of theabsorption capacity or the degree exudation in accordance with the typeof wound, through the selection of the appropriate side to be applied.

These measures allow for the prevention of the frequent phenomenon ofwound maceration, which occur when a dressing with limited absorptioncapacities (such as with, for example, a pure foam pad) isover-saturated with exudate.

In particular, it can furthermore be intended that, in the case that itis so intended, it be designed such that active substances, at leastpartially, remain in the dressing. In this manner, a bacterial growth inthe dressing as a result of absorbed exudate which contains bacteria maybe prevented. This last process is of particular significance becausesome of the dressings specified—particularly those containingsuper-absorbers—absorb large quantities of fluid, and therefore may beleft on the wound for long periods of time. Because the dressing issterile, and in accordance with the invention contains nutrients, thepotential for an enhanced bacterial growth would otherwise need to beaccounted for.

In addition, the exudate takes on two roles in said design version. Onone hand, it is in many cases a fluid for removal, which, by absorptionin the dressing, significantly promotes the healing process. On theother hand, the exudate serves as a dissolving agent for the substancesor complexes of substances mentioned, and contributes thereby to thedissolving of said, and the introduction, or diffusion, at least inpart, to the wound. This last process is of particular significancebecause some of the dressings mentioned—particularly those dressingswhich contain super-absorbers—absorb large quantities of fluid, and can,therefore, remain on the wound for a long period of time. As a result,in many cases, enough time is available for diffusion processes.

As a result of delayed solubility of the substances or complexes ofsubstances mentioned, a sustained-release effect, i.e. a treatment ofthe wound over a longer period of time, is enabled.

In a further, alternative design version, it is intended that the, atleast one, substance or complex of substances be introduced in asolution.

Such a solution may be used, for example, for a defined moistening ofthe dressings, in particular for such dressings that containsuper-absorbent particles. In this manner, on the one hand, a healingpromoting, moist environment is generated, and on the other hand, thenutritional and/or disinfecting functions are observed. Asustained-release effect can also be observed with a dressing which hasbeen prepared in this manner, i.e. a gradual treatment of the wound isobtained over a longer period of time.

In particular, water, but also, for example, a physiological salinesolution, Ringer's solution, blood serum, or plasma, may be used as adissolving agent.

There are dressings known of that contain super-absorbing particles andare impregnated with a physiological solution that are used as cleansingdressings for wounds. These solutions are so-called Ringer's solutions,having an electrolyte composition corresponding to the plasma of thesubject (i.e. 8.60 g NaCl, 0.30 g KCl and 0.33 g CaCl₂). This is not asolution with nutritional or even disinfecting properties, as thesubstance quantities selected are quite small, and insufficient in theircomposition. In addition, the use of topical medicines or disinfectingagents in combination with such dressings is expressly advised against.

Additionally, these dressings are primarily for cleansing purposes, anddo not correspond to treatment as defined in accordance with theinvention.

Ideally, it is furthermore intended that the, at least one, substance orcomplex of substances be incorporated in a cream, an ointment, a milk, agel, a suspension, emulsion and/or dispersion.

In an equally preferable version of the present invention, it isintended that at least one substance be made available through a processselected from the following group: freeze-drying, lyophilization, spraydrying, roller drying, and/or vacuum evaporation.

These types of preparation result in products which dissolve withoutresidue on contact with fluid. Products of this sort are also known as“instant” products.

It is also intended preferably that the composition or respectively, itscomponents, be available in sterilized form.

This can, for example, result from treating the composition withethylene oxide and/or gamma radiation. Furthermore, a separatesterilization of the dressing (e.g. with ethylene oxide) and thecomposition (e.g. through autoclaving) and later combining of thecomponents under sterile conditions is also possible.

Particularly preferable in accordance with the invention, is that with adisinfecting functioning complex of substances and a composition of atleast one vitamin or vitamin derivative, a metal ion, as well as adetergent, is used. This composition is a preferred example for theuppermost defined “disinfecting complex of substances.”

A composition of this type is already described in the WO2006116983 interms of the substances. However, this only describes the use of thiscomposition as a decontamination solution for surfaces, but not its usefor disinfecting wounds. As the expert knows, agents suited todisinfection of the surface are not necessarily suited to disinfectionof wounds. Examples of this are, e.g. 70% ethanol, phenol baseddisinfection agents, or radiation, or disinfection processes based ontemperature effects. The present invention shows for the first time, andsurprisingly, the effectiveness of these compounds for disinfectingwounds.

This is surprising particularly because, for the expert, theeffectiveness of a combination of substances, comprised of a vitamin orvitamin derivative, a metal ion, and a detergent is not immediatelyapparent to the expert. Everybody knows that these components alone donot exhibit disinfection properties. In addition, the experts avoid “offlabel use” of certain substances for other purposes.

The composition preferably has a pH value ranging from 2-8.5. Thiscombination of substances results in selective deactivation ofmicro-organisms. Particularly preferred is that the mixture has a pHvalue ranging from 3-7, ideally 4-6. Ideally, the composition contains abuffer as well comprised of carbonates and succinic acid derivatives. Byusing this buffer in the decontamination solution of the invention, thepH value of the solution, which is very acidic, due to the dissolvedcomponents, particularly the acidic vitamins, can be raised to aslightly acidic, or even neutral or slightly basic range, without lossof the dissolved metal ions.

The vitamins contained therein, or respectively, their salts or acidicderivatives are ideally selected from the group of water solublevitamins with anti-oxidative characteristics, such as preferably vitaminC, riboflavin and niacin.

Particularly preferred thereby is notably the combination of vitamin Cand vitamin E, or respectively, vitamin B12. A combination of this sortexhibits particularly synergistic effects with regard to disinfection.

The metal ions contained therein are preferably 2- and/or 3-valent ionsof metals from the 4^(th) period and/or the secondary groups I, II, andVIII [translator's note: “Nebengruppe”: “secondary groups,” a Germanconvention referring to the fourth period of the transition elements] ofthe periodic table of elements. They are used in their salt forms withorganic and/or inorganic acids or bases. Particularly preferred are oneor more compounds selected from the secondary groups VIII-XII,specifically iron, cobalt, nickel, copper or zinc.

The detergents are ideally anionic, non-ionic, amphoteric or cationicsurfactants, or suitable mixtures with or among each other. Inparticular, alkyl ether sulfate, alkyl- and/or arylsulfonate,alkylsulfate, amphoteric surfactants, betaines, alkylamidoalkylamine,alkyl substituted amino acids, alkyl substituted imino acids, acylatedamino acids, or surfactant combinations may be used. Particularlypreferred are anionic and non-ionic surfactants.

The specified substance combinations can be incorporated by themselvesor together with the composition of the invention in a water solublematrix, a flat pad, a protective dressing, a foam pad, a carboxymethylcellulose pad, a dressing containing super-absorbing particles, asolution, a cream, an ointment, a milk, a dispersion, a suspension or agel.

Further preferred disinfecting substances or complexes of substances tobe used are the so-called BLIS (bacteriocin like inhibitory substances).These are proteins with antibiotic characteristics, which are producedby various types of bacteria. They are useful in the framework of a“bacterial replacement therapy,” particularly in fighting certainstreptococci. Examples of BLIS of this type are colicin from colibacteria, nisin from Lactococcus lactis or the BLIS from Streptococcussalivarius K12. These may be obtained in dried form (similar to thedried yogurt culture available in stores), such that upon contact withmoisture, particularly exudate, they become active.

In this regard, it may also be intended that recombinant micro-organismsbe used in the composition, which, in the course of recombination, losethe characteristic of producing and releasing BLIS or similar inhibitorsto pathogenic micro-organisms.

Both the BLIS as well as, as the case may be, dried micro-organisms may,by themselves, or in combination with the composition of the invention,be incorporated in a water soluble matrix, a flat pad, a protectivedressing, a foam pad, a carboxymethyl cellulose pad, a dressingcontaining super-absorbing particles, a solution, a cream, an ointment,a milk, a dispersion, a suspension, or a gel.

Furthermore, octenidine, or respectively, octenidine dihydrochloride maybe used as a disinfecting substance or complex of substances. Octenidineor octenidine dihydrochloride is bactericidal with both gram-positive aswell as gram-negative germs, virucidal with lipophilic viruses such asthe herpes simplex and hepatitis B viruses. Furthermore, it isfungicidal, although not with spores. It is colorless and odorless, maybe applied painlessly, has a wide range of effects, and a retentiveeffect, and is therefore particularly suitable in combination with thecomposition of the invention.

Additionally, peroxides, such as hydrogen peroxide as well as hydrogenperoxide substances in combination with the composition of the inventionare suitable as disinfecting substances or complexes of substances.

Furthermore, other peroxides may be used as a disinfecting substance orcomplex of substances. Specifically, monoperphthalic acid, particularlythe substance magnesium monoperphthalate (MMPP), is meant here.

In addition, polyhexanide may be used as a disinfecting substance orcomplex of substances. Polyhexanide is a cationic diguanidine which isvery micorbiocidal, but not, however, virucidal or sporocidal. Due toits good tissue compatibility, polyhexanide is particularly suited forsensitive and poorly healing chronic wounds, as well as for long-termuse in cleansings as well as with semi-occlusive or occlusiveapplications, e.g. in keeping wounds moist, and is thereforeparticularly suitable in combination with the composition of theinvention.

Furthermore, zinc oxide may be used as a disinfecting substance orcomplex of substances. Zinc oxide is antiseptic, and is also suitable asa disinfecting substance.

Further disinfecting substances or complexes of substances that may beconsidered are listed in the main group 33.B.1 of the red list, and areall to be considered in the contents of the disclosure of the presentinvention. In particular, this refers to ethanol (60-90%), 1-propanol(60-70%) and isopropanol (70-80%), boric acid, chlorhexidine gluconate,iodine tincture, Lugol's iodine, povidone iodine/PVP-I, mercurochrome,2-phenoxyethanol, phenol (carbolic acid), thymol, hexachlorophene,triclosan, Dibromol, and/or sodium hypochlorite.

Other disinfecting substances or complexes of substances to beconsidered are, particularly, silver, silver colloids, materialscontaining silver, or respectively, materials with the ability torelease silver ions, peroxide, mixtures and/or alloys of silver andcopper in an organic medium which, as the case may be, are enhancedwith, at least one, catalyst(s) selected from the group containingplatinum, platinum dioxide, titanium, titanium oxide, and titaniumdioxide, antibacterial components of honey, such as propolis, honeyenzyme, royal jelly etc., octenidine, antibiotics, antimycotics such asnystatin, griseofulvin, imidazole and its derivatives such asclotrimazole or tolnaftate, antivirals and similar items.

The mixtures and/or alloys of silver and copper in an organic medium tobe considered, which, as the case may be, are enhanced with at least onecatalyst selected from the group containing platinum, platinum dioxide,titanium, titanium oxide and titanium dioxide, are described inreference to the disinfection treatment of oral mucosa. The oxides inquestion can catalyze the effects of the composition, as they producenascent oxygen, which forms a silver oxide radical with silver, which inregard to disinfection is extremely effective.

In the sense of the claim, a composition containing at least onedisinfecting substance or complex of substances may be understood to bea natural sponge. A natural sponge of this type, of the demospongiaeclass, exhibits growth inhibiting characteristics in regard tomicro-organisms in order to provide protection from the colonization ofsessile organisms. These characteristics may also be useful regardingthe treatment of wounds, as a means of preventing bacterial growth inthe dressing and/or wound. In addition, these sponges also exhibitgrowth inhibiting characteristics regarding fungi and unicellularorganisms, as sponges of this type are capable of absorbing liquids, andare therefore ideal for the absorption of exudate.

Said natural sponge may be placed in thin slices, created throughthermal slicing for example, on the wound. It can also be incorporatedin an existing dressing, as is familiar to the applicant of the presentinvention from, for example, the patent applications EP1411874,EP1507498 or DE202006016821U. Furthermore, it may be intended that thenatural sponge in question have super-absorbent polymers. This isparticularly advantageous because the containment capacity for woundexudate may be further increased and simultaneously the growthinhibiting characteristics of the sponge prevent bacterial growth in theexudate which is absorbed.

In addition, the composition containing at least one disinfecting, orrespectively, decontaminating substance or complex of substances, mayalso have the previously described super-absorbent polymers. If theseare impregnated with a solution containing bacteria, such as apathological substrate, they then serve to restrain, particularly, thebacteria, and prevent in this manner a recontamination of the wound bythe dressing. In this case, electrostatic exchanges between the polymersand the bacteria cell walls play a role.

Furthermore, the composition, which contains at least one disinfecting,or respectively, decontaminating substance or complex of substances, mayhave one or more exudation promoting substance. These substances are tobe understood as substances that promote exudation in a wound. Thepromotion of exudation is specified particularly for contaminated and orinfected wounds, whereby an increase in exudation results in animprovement of the rinsing of germs and other contaminants from thewound, and as a result, in decontamination. Particularly regardingcontaminations of a chemical, biological or nuclear manner, this is verybeneficial.

For this, for example, petroleum based blistering compounds, such asshale oil sulfonate, described here, may be used, as well as thehygroscopics also described.

Particularly preferred here are also combinations of one or morehygroscopic and one or more detergents. This combination may be, forexample, comprised of glycerin, as a hygroscopic and a non-ionicdetergent such as Pluronic F68. The components may be incorporated in adressing, which, when applied to the wound releases the components inquestion, thereby promoting wound exudation and supportingdecontamination.

In addition, a mixture containing magnetic particles (“beads”) may alsobe understood as the composition containing at least one disinfecting,or respectively, decontaminating substance or complex of substances,which has a functional surface. The functional surface may contain, forexample, antibodies that block surface antigens of certain pathogenicgerms. Furthermore, the surface may contain agents which bindcontaminants, such as bacterial toxins, cell debris and similar items,either specifically or nonspecifically.

These beads may be made available, for example, in a solution, andthereby introduced to the wound (“passive introduction”). Theintroduction into the wound may also be forced using a repellingmagnetic field (“active introduction”) which is achieved either with apermanent magnet or an electromagnet, or by using an attracting magneticfield as well, which is applied to the back side of the respective bodypart to be treated.

The functional surface may consist of a silicate surface, on whichproteins, such as antibodies or the like, are covalently attached. Saidbeads are preferably between 200 nm-1,000 μm in size, and made offerromagnetic material, such as iron, nickel, and cobalt and theiralloys.

The beads are, as described, introduced to the wound either passively oractively, where they come in contact with the exudate, remain for adefined period of time, and bond to the desired targets. Subsequentlythey are concentrated using either a permanent magnet or anelectromagnet, and removed from the wound. For this, a bandage may beapplied to the wound which has an absorbing material on the side facingthe wound and a magnet on the reverse side. The beads are attracted tothe magnet with their targets intact, and drawn into the absorbingmaterial, where they remain and may be removed in conjunction with thebandage.

In the same manner, a foam dressing, an alginate dressing, a film orfleece type protective dressing, a CMC pad, and activated carbon pad, ahydro-fiber pad, a hydrocolloid bandage, a gelatin pad or cotton waddingmay be applied to the wound, and the patient may be subsequently placedin the active field of a permanent magnet or an electromagnet. In thismanner, said product functions as an absorbing agent for the magneticparticles and the attached targets. For this, it may be intended thatsaid product also contain metal ions. Further designs of this inventiveprinciple are possible, which the expert, based on these descriptions,has received sufficient technical information to be able to determine,without the need of taking any inventive steps.

Regarding certain disinfecting substances or complexes of substances,the use of the composition of the invention with a dressing that isdesigned such that the dressing remains and nothing migrates into thewound may also be preferred. This can be particularly useful inpreventing germ growth in the, as the case may be, sterilized dressing,which would otherwise be promoted through, among other factors, theintended nutritional components such as glucose and amino acids.

In this case, the previously described silver donors are intended,although quaternary ammonium compounds (QAV) such as benzalkoniumchloride, cetyl trimethylammonium bromide, cetyl pyridinium chloride orbenzethonium chloride, or cationic surfactants such as distearyldimethyl ammonium chloride or esterquats also work.

These are organic ammonium compounds, whereby all four valences of anitrogen atom are organically bonded. QAV accumulate in cell membranesof living organisms and are able to thereby affect the function of thecell membrane. As a result of this effect, the cationic surfactants inparticular can also be used as disinfecting agents. Because theyexhibit, among other things, skin irritant characteristics, it istherefore intended that they remain in the dressing, and are used thereparticularly for the inhibition of bacterial growth in the dressing. Theimmobilization preferably results from covalent bonding of the QAV tothe material of the dressing.

In another, equally preferred design of the invention, it is intendedthat there be a composition containing at least the components of anenteral and/or parenteral dietetic composition. For this, the componentscontained therein are an example of the above defined “nutritionalsubstances.”

A parenteral dietetic composition contains as a rule electrolytes, i.e.minerals, carbohydrates (usually in the form of glucose), amino acids,fat and fatty substances (lipids) as well as vitamins and traceelements, and is suited to long-term exclusive nourishment of a patient.Usually these components are found in molecular forms having lowermolecular weights, which, in the case of application to a wound, maketheir absorption in the tissue of the wound particularly easy. Inparticular, proteins are not included, as they can cause complications,such as allergic reactions with parenteral infusion as well as with theapplication in wounds.

An enteral dietetic composition is usually more complicated than aparenteral dietetic composition, i.e. it contains components havinghigher molecular weights, in particular proteins.

The composition can thereby be comprised of a fully balanced dieteticcomposition, or a dietetic composition, as well, in which certainnutrient groups, in particular, for example, carbohydrates or roughageare removed while retaining the rest of the substances in an unalteredstate, or a dietetic composition which is enhanced with othersubstances. In regard to this, see example 1-3.

In this manner, in order to inhibit bacterial growth, for example,glucose and other carbohydrate sources may be omitted. For the samepurpose, anti-bacterial substances or complexes of substances may beincluded, as is explained further below.

Furthermore, the composition may contain in part the so-called Brottrunkor a Brottrunk dehydrated extract. This is a drink derived from a lacticacid fermentation of whole grain sourdough bread, and is rich innutrients or nutrient compounds, particularly zinc, iron or magnesium aswell as the vitamins A, B1, B2, B6, B12, C, D, E, biotin, niacin, folicacid, and pantothenic acid. The lactic acid bacteria used in theproduction of said belongs to the type Lactobacillus reuteri and isstill active, due to the absence of pasteurization. Because of its lowpH value as well as the living lactic acid bacteria, this substrate isable to inhibit matrix proteases (see below). Said dehydrated extractcan be produced through freeze-drying, for example.

The specified dietetic composition may be used as such, or incombination with the composition of the invention in a water solublematrix, a flat pad, a protective dressing, a foam pad, a carboxymethylcellulose pad, a dressing containing super-absorbent particles, asolution, a cream, an ointment, a milk, a dispersion, a suspension or agel.

In addition, it may be intended that the nutrient substance or complexof substances contains insulin, recombinant insulin, proinsulin, aninsulin-like growth factor (IGF), an insulin mimetic and/or a diabeticspecific, non-glucose, or -sucrose based energy source.

These substances also ensure a topical nutritional treatment of a wound,and are therefore included in the above definition. In this manner,insulin applied topically results in an increased absorbance of glucosethrough the cells to the affected area. The same applies to proinsulin,insulin-like growth factors, or insulin mimetics, in other words,molecules that have insulin-like effects in organisms. This type oftopical treatment can be shown particularly with diabetics. In thiscase, the cellular, insulin imparted ingestion of glucose issignificantly impaired as a result of a, at least temporary, deficiencyof insulin. In this regard, it is particularly significant thatdiabetics frequently suffer from chronic edematous wounds such as venousulcers and the like. A topical insulin therapy can significantly promotethe healing process.

In this combination, diabetic specific, non-glucose or -sucrose basedenergy sources can also be beneficial. This includes in the following,particularly, fructose, galactose and other non-glucose or -sucrosebased energy sources (fatty acids etc.). The expert can readily find inthe relevant literature other diabetic specific non-glucose or -sucrosebased energy sources without the need of taking any inventive steps.

Furthermore, it is preferably intended that proteases inhibitingsubstances or complexes of substances are proteases inhibitors,super-absorbent polymers, and chelators for divalent cations, coatedmagnetic particles, collagens, and/or an acidifying substance and/orcomplex of substances.

Thereby, it is preferably intended that for the acidifying substancesand/or complexes of substances, an active element is selected from thegroup containing: acids, buffers, non-pathogenic acid producingmicro-organisms, probiotics and/or symbiotics.

Chronic wounds frequently have a pH value in the alkaline range, i.e. apH value which is higher than the normal pH value of the skin (pH 5.5).The said acidifying active elements are ideally organic acids. These arepreferably formic acid, acetic acid, fruit based acids such as citricacid, malic acid and tartaric acid, lactic acid, gluconic acid,α-hydroxycaprilic acid, fumaric acid, or succinic acid. The expert canreadily find in the relevant literature, without resorting to anyinventive steps, other suitable acids as well. A portion of these acidsmay be made available in crystal form. Another portion of these acids isavailable in liquid form.

The buffer is ideally a buffer that is effective in acids. This may be,for example, an acetic acid/acetate buffer or an aluminum-iron-buffer.Particularly preferred buffer systems are the buffer systems in theblood of mammals, specifically, the carbonic acid-hydrogen carbonatebuffer system (H₂CO₃+H₂O

H₃O⁺+HCO₃ ⁻), phosphate buffer (H₂PO₄ ⁻+H₂O

H₃O⁺+HPO₄ ²⁻), protein buffer (buffer effect through amphoteric (plasma)proteins or, as the case may be, hemoglobin (Hb⁺H⁺+H₂O

H₃O⁺+Hb).

The expert can find in the relevant literature, without the need of aninventive step, other suitable buffers as well.

The said acids and buffers in combination may be incorporated as such,or in combination with the composition of the invention, in a watersoluble matrix, a flat pad, a protective dressing, a foam pad, acarboxymethyl cellulose pad, a dressing containing super-absorbingparticles, a solution, a cream, an ointment, a milk, a dispersion, asuspension, or a gel.

The non-pathogenic, acid producing bacteria are ideally lactic acidbacteria. For this, ideally bifidobacteria, lactococci, lactobacilli,preferably of the types Lactobacillus rhamnosus, Lactobacillusacidophilus, Bifidobacterium infantis, Bifidobacterium Longum,Bifidobacterium breve, Bifidobacterium lactis, Lactococcus lactis,Streptococcus themophilus, Lactobacillus johnsonii, Lactobacillusdelbrueckii, Lactobacillus neuter, Bifidobacterium animalis,Lactobacillus plantarum, Lactobacillus casei, Lactobacillus salivarius,Lactobacillus bulgaricus, Lactobacillus acidophilus DDS-1, Lactobacillusparacasei, and/or Lactobacillus sporogenes are intended.

With all of these bacteria, it is intended that they metabolize sugarand other substrate (particularly lactose and pre-biotics, see below)anaerobically, thereby producing lactic acid (lactate). They cangenerate thereby a pH value between 4.5-4.0 in the surroundingenvironment and in this manner contribute to the inhibition of the saidproteases. In addition, because they are not pathogenic (in particular,they are not inflammatory), lactic acid bacteria can competitivelycontribute to the inhibiting of pathogenic micro-organisms in the wound,e.g. as nutrient competitors, through the precipitation of inhibitors orby producing an acidic environment which is not suited to the specificpathogenic micro-organisms. The expert can find other suitablenon-pathogenic, acid producing bacteria in the relevant literaturewithout the need taking any inventive steps.

In this regard, it may also be intended that recombinant micro-organismsbe incorporated in the composition, which, in the course of recombininglose the characteristic of forming and releasing pathogenicmicro-organism inhibitors.

These non-pathogenic, acid producing bacteria can, for example, be madeavailable in dehydrated form (similar to dried yogurt culture availablein stores), such that they may become active on contact with moisture,in particular, with exudate. The said lactic acid bacteria arefrequently referred to as probiotics.

The said prebiotics are substances which represent a selectivenutritional basis for the said non-pathogenic, acid producing bacteria,and thereby promote their reproduction, or, as the case may be, promoteexisting pathogenic germs. They are in, for example, chicory, blacksalsify, Jerusalem artichoke, and many other unprocessed, or minimallyprocessed vegetable foodstuffs which contain prebiotics. Examples ofprebiotics are fructooligosaccharide, insulin,transgalactooligosaccharide, xylooligosaccharide, mannooligosaccharide,Jerusalem artichoke juice powder or lactulose. The expert can find othersuitable prebiotics as well in the relevant literature, without the needof taking an inventive step. These probiotics can exhibit an acidifyingeffect in and of themselves, particularly when already existingnon-pathogenic, acid producing bacteria in the wound are encouraged togrow through their presence, thereby generating an acidic environment.

Symbiotics is a general term for the mixture of probiotics andprebiotics.

The micro-organisms, which, as the case may be, are available indehydrated form, as well as the prebiotics and symbiotics may, in and ofthemselves, or in combination with the composition of the invention beincorporated in a water soluble matrix, a flat pad, a protectivedressing, a foam pad, a carboxymethyl cellulose pad, a dressingcontaining super-absorbent particles, a solution, a cream, an ointment,a milk, a dispersion, a suspension or a gel.

Said proteases inhibitors inhibit proteases in the affected area whichmay become harmful in the course of the healing process, particularly inpathological exudate (see above). These are, particularly, matrixmetalloproteinases (MMP), whose catalytic properties are partiallydependant on a respective metal ion (e.g. Ca²⁺, Zn²⁺). In particular,the metal matrix proteases MMP-1-MMP-10 are familiar. For this, ideally,the use of so-called TIMPs (“tissue inhibitors of matrixmetalloproteinases”) is intended. These are proteins which contain theactivity of the MMPs through specific bonds to their catalytic centers.In the regeneration phase of the wound, harmful destruction andreconstruction of the tissue by MMPs can thereby be prevented. Theprimary candidates for this are, in particular, TIMP-1, TIMP-2, TIMP-3,and TIMP-4.

Said chelators can bond bivalent metal ions, thereby reducing theaverage concentration of said cations, and as a result, reduce theactivity of the metalloproteinases. These are, for example, EGTA orEDTA.

Furthermore, aside from water, super-absorbent polymers can also bondwith proteins and bivalent cations. The bonding of proteins alsoincludes, as experiments have shown, the bonding of matrix proteases.These are extracted from the exudate and bonded, thereby removing themfrom the affected area. The bonding of bivalent cations also contributesto the deactivation of the matrix proteases. For these reasons,super-absorbent polymers may also be regarded as a compositioncontaining at least one proteases inhibiting substance and/or complex ofsubstances.

The characteristics mentioned are basically known. It has also beenreported that dressings containing super-absorbent polymers moistenedwith Ringer's solution can deactivate metalloproteinases through directbonding or bonding with bivalent cations (Smola et al.,“Polyacrylate-superabsorber inhibits excessive metalloprotease activityin wound fluid from non-healing wounds”, abstracts of the ETRS annualmeeting, Pisa, 2007).

With dressings containing super-absorbent polymers moistened withRinger's solution, cleansing agents are applied to the wound and in acyclical process release Ringer's solution to the wound and then absorbsaid, thereby cleansing the wound. During the cleansing process, matrixproteases and bivalent cations are also washed out of the wound andtransported to the dressing, where they are bonded to thesuper-absorbent polymers to be found there. Due to the passive cleansingprinciple, this is however a very lengthy process, which requires moretime than the period of time in which the dressing is applied to thewound.

In contrast, the use of super-absorbent polymers in a basically dry,absorbent dressing, as is suggested here, for the first time, by theinventor, results in a net absorption of fluid, particularly exudate,and thereby a much faster bonding of matrix proteases and bivalentcations.

Furthermore, a mixture containing magnetic particles (“beads”) may alsobe understood to be a composition containing at least one proteasesinhibiting substance and/or complex of substances, which has afunctional surface. Said functional surface may contain antibodies thatblock one or more matrix proteases. Additionally, said surface maycontain a substrate for matrix proteases, such as collagen (particularlycollagen type IV), to which proteases freely bond through theirsubstrate bonding regions.

The active principle, as well as any material designs, has already beendescribed in the preceding. The beads are introduced to the wound eitherpassively or actively, where they come in contact with the exudate,remaining for a period of time and bonding to the desired matrixproteases. Subsequently, using either a permanent magnet, or anelectromagnet, they are concentrated, and removed from the wound. Forthis, a bandage may be applied, for example, to the wound, with anabsorbent material facing the wound, on the back of which a magnet isattached. The beads are attracted to the magnet with their targetsintact, and arrive in the absorbent material, where they remain and maybe removed from the wound together with the bandage. A vacuum therapymay also be advantageous in combination with the previously mentioneduse of magnetic particles.

For the first time, using the described mechanics of magnetism, specificenzymatic activity as well as mechanisms relevant to enzyme kineticinhibition are combined in the field of wound treatment, and incombination, allow for manipulations of the healing process reaching adepth in the tissue which otherwise could only be achieved with surgery.An incision in healthy tissue, or application through systemic means,seems comparatively unfavorable, even when it is not know how deeply theinfluence reaches.

The construction of the combination over a clasp shaped, hobble-typering construction with opposing, identical or temporarily subsequentlyarranged polarization is conceivable.

The aim is to use magnetic forces in existing interstitial pathways inorder to transport substances to the regions below the surface of thewound which have the desired effect on the healing process throughcontrolled characteristics. In this manner, a directed transportation ofsubstances into the depths of the tissues and back again is obtained.Using extra substrate in the form of collagens that bond to theproteases and can thereby be subsequently removed magnetically alsoforms a possibility. Hygroscopic substances, surfactants, nutrients, allclasses of pharmaceuticals and groups of substances (=for the treatmentby medicinal complexes suited to diseases) as well as other substancesand complexes may be introduced which are permanently bonded to magneticparticles.

The substances which are introduced may be applied to the wound surfaceusing various means; for example, through aerosols, fluids orgranulates.

These combinations may be capable of releasing substances, such asmedicines, to the depths of the tissues, in order that they are not onlyactive on the surface, but in addition, pharmaceutically effectiveprocesses, imaging processes with contrasting agents, antibioticmeasures, cytostatic steps, immune system modulations, acidifying theaffected area or formation of complexes may also be initiated.

Furthermore, the use of collagens by themselves can also have aproteases inhibiting effect, which has to do with the principle ofcompetitive inhibition. The basis of this principle is that proteasesoffer an excess of a substrate, collagen, which are attacked by saidfirst. They thereby perform their function either not at all, or in areduced manner within the affected area. The use of collagens, however,also has other benefits which will be explored further below.

In addition, the composition may also contain analgesic substances, i.e.pain relievers. For this, essentially all of the substances that arelisted in the main group 05 of the so-called “red list” may beconsidered. Particularly preferable thereby are specificallyanti-inflammatory substances such as, so-called COX inhibitors or NSAID(non steroidal anti-inflammatory drugs), as well as, for example,propionic acid derivatives, such as naproxen, ibuprofen, ketoprofen,fenoprofen, flurbiprofen, dexibuprofen, or tiaprofenic acid, acetic acidderivatives such as diclofenac, alclofenac, etodolac, aceclofenac,sulindac, or indometacin, heterocyclic acetic acids such as ketorolac,arylalkanoic acids such as tolmetin, N-phenylacetic acids such asmefenamic acid or flufenamic acid, salicylates such as acetylsalicylicacid (aspirin), salicylic acid, or diffunisal, pyrazolone derivativessuch as phenylbutazone, oxicam derivatives such as piroxicam, tenoxicam,meloxicam, or lornoxicam, enolic acid derivatives such as aminopyrine orantipyrine, phenols such as acetaminophen and similar items. Inaddition, there are the COX-2-inhibitors such as rofecoxib, lumiracoxibor celecoxib.

Furthermore, substances which are not anti-inflammatory may also be usedas pain relievers, such as, for example, opiates, local anesthetics suchas lidocaine, mepivacaine, prilocalne, procaine, syntocaine, tetracaine,Gingicaine, articaine, bupivacaine, butanilicaine, chloroprocaine, orfor example, polidocanol.

In addition, the composition may contain anti-inflammatory substancesthat, as the case may be, exhibit secondary analgesic properties, suchas, for example,—aside from the above named, which in part are alsoanti-inflammatory analgesics—hormones, particularly cortisone andcorticoids, specifically glucocorticoids (e.g. cortisone, cloprednol,prednisone, prednisolone, methylprednisolone, deflazacort,fluocortolone, triamcinolone, dexamethasone, betamethasone) andmineralocorticoids (e.g. aldosterone, desoxycorticosterone,fludrocortisone).

As a rule, it may be beneficial to overdose the wound beyond the acutetreatment needs with said substances or complexes ofsubstances—particularly the nutrients, disinfectants and/or, as the casemay be, the analgesics—as, for example, portions of the substances willremain in the dressing. This overdosing serves, however, not to resolvethe overall insufficiency of the nutrients in a patient, or to preventsystemic sepsis, because a systemic effect, as is mentioned above, isneither intended nor desired. Nevertheless, the selected dosage may behigher than the dosage, as will be explained in the following, which isthe recommended oral or enteral daily dosage. This is useful inparticular because, for example, in the end the application of thecomposition in a dressing should frequently remain on the dressing for alonger period of time.

If it is the case that compositions are used, for example, that containa dietetic composition, it is particularly intended that the amountused, for example, per dressing (e.g. foam pad, or dressing containingSAP) lies in the range between 10% and 200% of the DGE (DeutscheGesellschaft für Ernährungsmedizin[: German Society for NutritionalMedicine]) recommended daily dosage. It is particularly preferred thatthis lie in the range between 30% and 100% of the recommended dailydosage.

The said composition can, thereby, be incorporated in the dissolved formof dressing, for example, or, respectively, incorporated in the dressingin advance. Alternatively, the composition may be incorporated in thedressing in its dehydrated form.

In the case that, for example, compositions are used which containdisinfecting substances, it is ideally intended that the amount used,per dressing, for example, be increased by a factor of 10 over therecommended daily dosage per kg bodyweight.

In additional preferred versions, the composition contains in addition,one or more substance(s) which are selected from the group containingorthomolecular nutrients, nutraceuticals, phytochemicals, antioxidants,growth factors, petroleum based blistering compounds, methylxanthines,tannins, tacrolimus, pimecrolimus, ATP, urea, sympathomimetic drugs,parasympatholytics, activated carbon, octenidine, polyhexanide,homeopathic remedies, Q10, thickening agents, karaja, pectin, agar, aloevera, hemostyptics, animal saliva such as maggot or canine saliva,spider web proteins, collagen, hygroscopics, glycerin, biofilm harmingsubstances, triacetin, zinc oxide, light absorbing components, odorinhibitors, gelling agents, exudation promoting substances, swellingreducing agents, radical scavengers, and/or honey or, respectively, itscomponents. Most of these components belong to the definitions givenabove of nutrients, disinfectants, and/or proteases inhibitingsubstances or complexes of substances.

Orthomolecular nutrients in the framework of the concept oforthomolecular medicine, an alternative medical process largelyinfluenced by Linus Pauling, are nutrients which are used, particularlyvitamins and minerals, and may be administered in part in the intendedhigh-dosage dosage-regimen.

Nutraceuticals are nutrients which are enriched with additionalsubstances (nutrition enriching agents), which should have a positiveeffect on health. These additives are primarily vitamins, minerals,bacteria cultures, and unsaturated fatty acids.

Phytochemicals are secondary plant material, in particular; these may becarotenoids, polyphenols and sterols. Among other properties attributedto said, are those of antioxidants and the fighting of free radicals, aswell as the promotion of immunity and the reduction of cholesterollevels.

Antioxidants are substances which prevent the oxidation of sensitivemolecules, particularly DNA and proteins. They usually function asradical scavengers. Antioxidants can be categorized as “antioxidants”,“reducing substances” and “antioxidants with synergetic effects.” Adefinition for the so-called true antioxidants is the mechanism wherebythe chain reaction resulting from the scavenging of free radicals isblocked.

Examples of such antioxidants are BHA and BHT. In contrast to this, forexample, ascorbic acid functions as a reducing agent by allowing lighteroxidation than that of the molecule being protected, thereby protectingsaid. Sodium EDTA belongs to this last group of synergisticantioxidants, for example, in that it enhances the antioxidant effect bybonding with metal ions.

In the framework of the present invention, the following antioxidantsare to be taken into consideration: Antioxidants belonging to thevitamin E group, carotenoids, particularly lycopene and β-carotene,glutathione, transferrin, albumin, ceruloplasmin, hemopexin,haptoglobin, antioxidant enzymes, particularly superoxide dismutase(SOD), glutathione peroxidase (GPX), and catalase, tin chloride,ascorbic acid (vitamin C) and its derivative sodium L-ascorbate, calciumL-ascorbate, isoascorbic acid, sodium isoascorbate, and ascorbylpalmitate, butylated hydroxyanisole, butylated hydroxytoluene, calciumdisodium EDTA, gallates, particularly propyl gallate, octyl gallate, anddodecyl gallate (lauryl gallate), lecithin, lactic acid, polyphosphatessuch as diphosphate, triphosphate, and polyphosphate, sulfur dioxide,sodium sulfite, sodium bisulfite, potassium sulfite, calcium sulfite,calcium bisulfite, potassium bisulfite, selenium, tocopherol (vitaminE), alpha-tocopherol, gamma-tocopherol, delta-tocopherol, tinII-chloride, citric acid as well as sodium citrate, calcium citrate, andreducing agents such as acetylcysteine.

As growth factors, growth relevant polypeptides are indicated, which aretransferred from one cell to another as a signal, thereby transferringinformation relevant to growth. They particularly play a role in thedevelopment of multi-cell organisms. The important growth factors are:

-   -   Transforming growth factor Beta (TGF-B)    -   Granulocyte-colony stimulating factor (G-CSF)    -   Granulocyte-macrophage colony stimulating factor (GM-CSF)    -   Nerve growth factor (NGF)    -   Neurotrophins    -   Platelet-derived growth factor (PDGF)    -   Erythropoietin (EPO)    -   Thrombopoietin (TPO)    -   Myostatin (GDF-8)    -   Growth differentiation factor-9 (GDF9)    -   Basic fibroblast growth factor (bFGF of FGF2)    -   Vascular endothelial growth factor (VEGF)    -   Platelet derived growth factor (PDGF)    -   Epidermal growth factor (EGF)    -   Hepatocyte growth factor (HGF)

Petroleum based blistering compounds have an exudation promoting effectas well as a necrolytic effect. For this reason, they may also functionin particular as decontaminants. One understands under this term theso-called black blistering ointments in particular, such as ichthyolbased compounds, but also shale oil sulfonates. Shale oil sulfonatessuch as ammonium bituminosulfate, for example, are water soluble througha sulfonation process. The said compounds may be incorporated inaccordance with the invention in a fatty or aqueous component of thecovering of the dressing, and be applied as the first contact layer to awound.

Methylxanthines are a group of alkaloids, which are usually used as mildstimulants as well as for treating bronchial asthma. They includecaffeine, theophylline, and theobromine. Xanthines are purinederivatives. They have a constricting effect and tend to reduceswelling, so that, as the case may be, edema in the affected area isreduced, and nutritional, disinfecting and/or proteases inhibitingsubstances are not diluted unnecessarily.

Tannins function as astringents, i.e. they serve to reduce edema, areant-inflammatory, antibacterial, antiviral, and neutralize toxins.

Tacrolimus (also FK506 or FK-506) is a macrolide from the bacteriaStreptomyces tsukubaensis. Tacrolimus is used as, among other things, aselective immuno-suppressive against rejection reactions in organtransplants. Tacrolimus is both immuno-suppressive and antimicrobial.Its effects can be compared with those of the polypeptide cyclosporine,but may be used in smaller doses. Tacrolimus intervenes in the metabolicprocess of T-cells, and inhibits their activity. It bonds to thecytosolic receptor, a so-called immunophilin within the target cell. Thecomplex comprised of immunophilin and tacrolimus adheres to theserine/threonine-protein phosphatase calcineurin. Calcineurin is therebyrendered inactive. The same basically applies for the substancetacrolimus.

ATP is a nucleotide, formed from the triphosphate of the nucleosideadenosine, and as such is an energy rich component of the nucleic acidsDNA and RNA. ATP is however also the universal form of directlyavailable energy in every cell and at the same time an importantregulator of energy providing processes. ATP can be released from energystores (glycogen, creatine phosphate) as it is needed. By adding ATP tothe composition of the invention, an energy source free of glucose ismade available, and is particularly useful in treatments where diabetesis present for improving the energy balance of the cells.

Urea has a high capacity for bonding with water and also exhibitskeratolytic properties. In addition, it serves as a source of moisturefor fighting atopic eczema and lichen diseases and is thereforeparticularly suited for use in a composition in accordance with theinvention.

Necrolytes are agents which eat away at necrotic tissues. These may, forexample, be the petroleum based blistering compounds described here.Other possible necrolytic agents are, for example, urea or animalsaliva, both of which will be described below.

Sympathomimetics have a stimulating effect on the sympathetic portion ofthe autonomic nerve system. They affect an increase in blood pressureand pulse rate, a dilation of the bronchial passage, an overallimprovement in performance and an increase in energy consumption. Incombination with the composition of the invention, these substancesreduce swelling as well as edema.

Parasympatholytics are medicines which counteract the action of theparasympathetic nervous system. The therapeutic use ofparasympatholytics is complicated by insufficient organ selectivity. Inthis manner atropine, as a medicine for chronic obstructive bronchitis,promotes not only dilation of the bronchial tract, but also stimulatesthe heartbeat, dilation of the pupils, and a contraction of the smoothmuscles. Use of these substances has a comparable effect to thesympathomimetics described above.

Activated carbon is a fine-grained carbon with a large internal surface,which is used in, among other things, chemistry, medicine, water andwaste treatment as well as ventilation and air conditioning technology.When incorporated in a composition in accordance with the invention, itcan contribute to bonding with toxins arising from metabolic processesand germs, and thereby, cleansing of the affected area.

Q10 or coenzyme Q10 is a quinone derivative with lipophilic terpenoidside chains, structurally related to vitamin K and vitamin E. CoenzymeQ10 is an essential electron and proton vector between the complex I orcomplex II and the complex III of the respiratory chains and can supportthe energy metabolism of the cells in the affected area throughresorption with nutrients in the framework of a composition inaccordance with the invention.

Thickening agents are added to solutions—as a rule, aqueous solutions—inorder to increase their viscosity. They are mainly able to bond withwater. Through extraction of unbonded water, the viscosity is increased.After a certain point has been reached, characteristic for each type ofthickening agent, additional moisturizing effects occur which usuallylead to an over proportional increase in viscosity. Thickening agents incombination with the composition of the invention allow for anadaptation to the surface of the wound, and a maximization of theresorption surface.

Suitable thickening agents are, for example, karaya (Indian tragacanth,karaya gum, E 416), a natural gum comprised of carbohydrates andgalacturonic acids (secretion of the Indian sterculia tree), alginicacid, agar, carrageen, locust bean gum, guar gum, tragacanth, gumArabic, Xanthan gum, karaya, tara gum, gellan, pectin, cellulose,cellulose ether, carboxymethyl cellulose, hydroxypropyl cellulose,hydroxypropyl methylcellulose, methyl cellulose, methyl ethyl cellulose,modified starch, egg yolk, roux, sago, and starch.

Pectins are vegetable polysaccharides, or specifically polyuronides,which for the most part are comprised of α-1.4-glycosidically linkedD-galacturonic acid units. Many micro-organisms are able to metabolizepectins. Due to their ability to create gels, pectins may also be usedas a thickening agent in the manner indicated above. In addition, theyare capable of functioning as chelating agents in the detoxification ofheavy metal poisoning, and are therefore particularly suited for use inthe framework of a composition in accordance with the invention.

Aloe vera is a plant from the aloe family which is produced in a gel ofthe same name, also called acemannan, having a long chainpolysaccharide. This substance stimulates the immune system in in-vitroexperiments, protects the cell membranes, and is antibacterial,antiviral, and antimycotic. This substance is absorbed into the bodyparticularly well through the gastro-intestinal tract, and can also beused, however, in the affected area. In addition, aloe vera containsminerals (calcium, magnesium, zinc, selenium, and others), vitamins,amino acids, and secondary plant substances (flavonoids). The term “aloevera,” for the purposes of the present invention, may also refer to aloevera extracts, the substances of which may be more easily absorbed bycells in the affected area.

Hemostyptics or haemostatics are substances which stimulate hemostasis,thereby making the healing process possible; in particular, vitamin K,coagulating factors (e.g. factor VIII, factor IX),trans-4-aminomethyl-cyclohexan-carboxylic acid, etc.

The term “animal saliva” refers particularly to canine saliva and maggotsaliva. Canine saliva, aside from having disinfecting agents, alsocontains necrolytic and granulation promoting substances, and in thismanner, can accelerate the healing process. Maggot saliva is the salivafrom insects used in the treatment of wounds, particularly maggots(notably, the common green bottle fly, Lucilia sericata,). Said insectsare able to cleanse chronic wounds of necrotic tissue and bacterialwaste. Aside from the removal of wound debris and bacteria, the healingprocess and the regeneration of fresh tissue is stimulated and promotedby substances, particularly enzymes, which are contained in the salivaof the common green bottle fly.

With said saliva, it may be particularly intended that it be producedthrough recombinant processes, i.e. genetically.

Spider silk is comprised of long chain protein molecules. The threadsproduced in the salivary glands of spiders, due to the special moleculararrangement of the amino acids involved, are very flexible, extremelyresilient, highly tensile, and at the same time highly elastic. Thegossamer filaments are light and water tight, having, however, a highcapacity for water absorption which is comparable to wool. They areresistant to microbial attacks and are therefore ideally suited for usein the composition of the invention, for example as sheathing materialfor a dressing containing the composition, or as a particulate,disinfecting substance. The term may also refer to synthetically,particularly recombinantly, produced spider silk.

Collagen is a structural proteins present in humans and animals in theconnective tissue. In the human body collagen is the largest portion ofprotein, comprising over 30% of the total mass of all protein. Collagenis suited, in combination with the composition of the invention, as aCa²⁺ scavenger for the reduction of proteases activity, particularly incombination with vitamin C. In addition, they also inhibit proteases, asis described above, in that they metabolize said.

Hygroscopy, in chemistry and physics, is the property of a substance (ahygroscopic) of bonding moisture in its vicinity (for the most part inthe form of vapor in humidity). Hygroscopics can also, in particular,absorb exudate, and are therefore particularly suited for use incombination with the composition of the invention. Examples aresuper-absorbent polymers, glycerin, silicates such as silica gel,melissic acid and similar items. Said hygroscopics may also have, inparticular, an exudation promoting effect, and thereby promote andenhance decontamination of the wound.

Triacetin (glycerin triacetate) is an ester compound comprised ofglycerin and acetic acid. It is antimicrobial, and is used as asoftener, and due to its hygroscopic properties is also used as amoisturizing agent.

Biofilms are comprised of a thin layer of mucus (film) in whichmicro-organisms (e.g. bacteria, algae, fungus, protozoa) are embedded.Biofilms are created when micro-organisms colonize on boundary surfaces.They form for the most part in aqueous systems, either on the surface ofthe water, or on a boundary surface of a solid. In more than 60% of allbacterial infections, the pathogens protect themselves from the immunesystem through the formation of biofilms. This includes microbialcontamination and colonization of catheters, implants and instruments.Substances which destroy biofilms are, for example, abrasive substances,such as lime powder, detergents or expectorants, agents withparticularly reducing effects, which can break up disulfide bonds. Theiruse in combination with the composition of the invention enables thereduction of germ colonization and thereby an improvement in thesupplying of nutrients and/or prevention of infection to the wound.

Furthermore, it may be intended that the composition of the inventionalso contain swelling reducing substances such as, for example, redeyebright (Euphrasia officinalis) extract, common sage (Salviaofficinalis) or cowslip (Primula veris), vasoconstrictors such asoxymetazoline hydrochloride or xylometazoline hydrochloride oranti-edemas. These may be helpful in reducing swelling in the affectedarea and to make edematous fluid available, in order that they may beabsorbed by an absorbent dressing.

Furthermore, it may be intended that the composition of the inventioncontain light absorbing components. These help to prevent the loss ofstructural integrity in light sensitive components (e.g. zinc oxide,vitamins).

Pigments, such as titanium dioxide for example, are particularly goodcomponents for light absorption. These can be incorporated in thesheathing or together with other components such as in a solution, anemulsion or similar items as well. In addition, they may be included inthe packaging of products. Said may, however, be stored in the dark ingeneral, in order to protect the contents contained therein from light.

Odor inhibiting substances absorb malodorous substances, restrain them,or prevent their existence, thereby improving the quality of life of thepatients treated with the composition of the invention. These may be,for example, activated carbon, herbal extracts, perfumes and similaritems.

In general, all of the disinfecting substances or complexes ofsubstances have odor inhibiting properties.

Furthermore, the composition of the invention may contain gellingagents, such as, for example, agar, gelatins, acrylamides, agaroses, orUV-curable gelling agents. Using these, a gel may be formed on thewound, which on one hand acts as a cover for the wound, ensuring thatthe wound remains moist and protected, and on the other hand, acts as acarrier and donor of the substances or complexes of substances named,and ensures a supply of said to the wound.

Radical scavengers deactivate free radicals, which otherwise placebiological tissue under oxidative stress, and initiate chain reactionswhich can generate damage to cells and tissues, particularly changes inthe cellular DNA. These may be, in particular, epigallocatechin gallate,superoxide dismutase, glutathione peroxidase, vitamin A, vitamin C,vitamin E, coenzyme Q10 and anthocyanins. Bilirubin and uric acid arealso able to neutralize free radicals, as well as the hormone melatonin.Radical scavengers are also frequently antioxidants. Particularly idealthereby is notably the combination of vitamin C and vitamin E. Acombination of this sort exhibits a particularly synergistic effect inregard to the antioxidative effect.

Honey consists 70-80% (mass) of inverted sugar, and contains,furthermore, enzymes, vitamins, amino acids, pollen, flavorings, andminerals. It has an antibacterial effect and is also hygroscopic, andfor these reasons is particularly beneficial in combination with thecomposition of the invention.

Furthermore, it is particularly intended that there be one or morevitamins, selected from the group containing vitamin B12, vitamin D,vitamin C vitamin B1, vitamin B2, vitamin B6, niacin and/or folic acidin the vitamins.

An insufficiency of vitamin B12 (cobalamin) can lead to perniciousanemia (Perniziosa), a disease in the blood count and funicularmyelosis. The causes of these insufficiencies may be an insufficientsupply of nutrients, as has been observed with vegans, or insufficientresorption. With insufficient receptivity in the gastro-intestinaltract, the organism is lacking the intrinsic factor in its gastricjuices, a glycoprotein which is produced by the parietal cells of thestomach and is essential for the metabolism of vitamin B12. Theintrinsic factor binds cobalamin in a complex protected from thedigestive system, and in this manner enables it to be transported in thestomach cells whereby vitamin B12 is able to arrive at the externaltissues by bonding with other proteins (transcobalamin). A disturbancein the absorption in the terminal ileum may lead to insufficiency.Although a direct link to the healing process is unfamiliar to somesources, vitamin B12 is however one of the vitamins that typically needto be supplemented in older people.

Vitamin D is a collective name for a group of fat soluble vitamins whichhave numerous physiological effects. Its main representative in humans,vitamin D3 (or cholecalciferol) is a prohormone which the body producesin the skin with the aid of UVB light or can be supplied nutritionally.

Vitamin C is an organic acid. Because it is easily oxidized, it hasantioxidant properties. Its most important property is the physiologicalfunction as a vitamin. Insufficiency can result in scurvy in humans.Vitamin C is a radical scavenger and exhibits antioxidant properties (itfunctions, in other words as a reduction agent). It is an importantco-factor in the hydroxylation reaction and, among other things, enablesthe body to produce its own collagen thereby. Furthermore, it plays animportant role in the production of amino acids. It protects otherimportant metabolites and the genotype from oxidation through itsantioxidant effects, or, respectively attacks from free radicals, whichin the end means it provides protection to the cell from damage andthereby from cancer. Together with niacin and vitamin B6, vitamin Ccontrols the production of L-carnitine, which is needed for the burningof fat in the musculature. In addition, it improves resorption of ironin the small intestine.

Thiamin or vitamin B1 is a water soluble vitamin in the B-complex havinga weak, but characteristic odor and is particularly essential to thefunction of the nervous system.

Vitamin B1 is necessary for the burning of carbohydrates, whereby itconsumes itself as a co-enzyme. As the brain and the nerve cells aredependant on energy from carbohydrates, an insufficiency of thiaminparticularly affects all brain and nerve functions.

Vitamin B2 or riboflavin serves as a preliminary step for flavinco-enzymes (FAD, FMN), which play a particularly major role inoxidoreductases, for example in citric acid cycles. It assumes a centralrole thereby in metabolism. Riboflavin dissolves poorly in water, issensitive to light, but is very resistant to heat. It contributes to asmooth complexion, and is involved in the regenerative mechanisms of theskin.

The phosphorylated vitamin B6 derivatives act as co-enzymes inapproximately 100 enzymatic reactions. Nearly all reactions take placein amino acid metabolism. The pyridoxal phosphate (PLP or PALP) (apyridoxine derivative) assumes another important function as a co-factorin the synthesis of Δ-aminolevulinic acid, an intermediary product inthe endogenous heme synthesis. Also noted is the participation ofpyridoxal phosphate as a co-factor in the breakdown of animal starch(glycogens). Insufficiency results in the existence of dermatitides andgrowth disorders.

Niacin or nicotinic acid is a carboxylic acid of pyridine. Nicotinicacid is present in all living cells and is stored in the liver. It is animportant building block of various co-enzymes (NAD, NADP) and is ofcentral importance in the metabolism of proteins, fats, andcarbohydrates. It is less sensitive to heat, light, and oxygen thanother vitamins in the B family. Nicotinic acid participates in themetabolism of proteins, fats, and carbohydrates. In the co-enzyme formNAD/NADP and their reduced forms NADH/NADPH, the so-called reductionequivalents, nicotinic acid is involved, for example, in the citric acidcycle and the respiratory chain. It is an antioxidant, and is involvedin numerous enzymatic processes. Nicotinic acid is important for theregeneration of skin, muscle, nerves and DNA.

Folic acid is sensitive to light, oxygen, and heat, as well as beingwater soluble. An insufficiency of folic acid in the body affects theblood count in that it may lead to a hyperchromatic macrocytic anemia.

Due to their metabolic-physiological characteristics, the vitamins namedhere, in particular—either alone or in combinations—have a significantinfluence on the healing process, specifically because they improve thelocal nutritional situation, and thereby contribute to an improvement ofthe local cell metabolism.

Particularly preferred thereby is notably the combination of vitamin Cand vitamin E. A combination of this sort has synergistic effects inparticular.

The substances named can be, without exception, in combination with thecomposition of the invention incorporated in a water soluble matrix, aflat pad, a protective dressing, a foam pad, a carboxymethyl cellulosepad, a dressing containing super-absorbent particles, a solution, acream, an ointment, a milk, a dispersion, a suspension, or a gel.

In accordance with the invention, in addition a dressing is intendedwhich contains a foam pad and/or super-absorbent particles,characterized in that this contains a composition in accordance with thepreceding description.

In addition, a dressing is intended containing super-absorbentparticles, characterized in that this contains a composition inaccordance with the preceding description.

Furthermore, a kit is intended of various compositions in accordancewith the preceding description, various pads in accordance with thepreceding description or various dressings in accordance with thepreceding description, which is characterized in that the variouscompositions, pads or dressings of the kit are in each case appropriatefor various phases of the wound.

In observing the healing processes, four phases of the healing processesmay be distinguished, specifically: the inflammatory or exudative phase(cleansing phase), the granulation phase, the epithelization phase, andthe reparative phase. The epithelization phase and the reparative phaseare occasionally considered as one.

1. Cleansing Phase

Particularly with acute wounds, hemostasis is of primary importancedirectly after the wound has occurred. The complement system(coagulation cascade) is activated, and loss of blood is limited bythrombocytes and aggregation of fibrin. This is supported by asimultaneous vasoconstriction. Subsequently, there is an increasedrelease of histamines and serotonins by the damaged cells. The resultingrecurrence of vasodilation with a simultaneous increase in vascularpermeability leads to the formation of wound edema. This can be seen bythe reddening and heating of the skin as well the resulting pain thepatient experiences. In a later part of the phase, the cleansing of thewound is of primary importance. Edematous fluid is exuded from theaffected area in the form of protein rich exudate, cleaning the wound.At the same time, leukocyte infiltration in the affected area isstimulated. This last aspect results as well due to mechanical cleansingof germs and excess tissue, supported by biochemical processes fordefense against germs and the active removal of irreversibly damagedtissues. The exudative phase serves to prepare the affected area for thefollowing phases of the healing process. This particularly applies tothe processes for chronic wounds, which do not always exhibit thebleeding mentioned at the beginning

2. Granulation Phase

If the wound exhibits the corresponding prepared areas resulting fromthe exudative phase, then within the subsequent two to four daysfibroblasts begin to collect and stroma is formed, also known asgranulation tissue. The regeneration of tissue develops along the fibrinmatrix of the blood coagulation and uses the supply of nutrientsresulting from the simultaneous regeneration of blood vessels(angiogenesis).

3. Epithelization Phase

Through the initiation of contraction of the edges of the wound, theamount of necessary regeneration of tissue is reduced and epithelizationphase begins. At this point, a regeneration of tissue begins at theedges of the wound, whereby keratinocytes or basal cells may beinvolved.

4. Reparative Phase

The epithelization is completed in the reparative phase, provided acorresponding prepared wound surface exists. The granulation tissue isconverted to scar tissue. At this point the vessels recede, and over thecourse of months or even years, a hard, fibrous scar tissue forms. Inthis phase, proteases (particularly matrix metalloproteinases) may havea particularly harmful effect.

The wound has different requirements during each phase, which are met bythe kit of the invention. In this manner, a kit may be assembled fromdressings equipped with four different compositions. A kit of this sortis described in the following table:

Requirements for treatment Ideal substances anticipated in the Phaseand/or care composition of the invention 1 1. Absorption of exudate 1.Super-absorbent particles 2. Inhibition of bacteria 2. Immobilizedsilver donors in the growth in the dressing dressing 3. Disinfection ofthe 3. Mixture of vitamins and/or vitamin wound derivatives, metal ions,surfactants 4. Inhibition of proteases 4. Lactic acid bacteria andprobiotics and/or TIMP and/or acids 2 1. Nourishing of the wound 1.Nutritional substances 2. Disinfection of the 2. Mixture of vitaminsand/or vitamin wound derivatives, metal ions, surfactants 3 1.Nourishing of the wound 1. Nutritional substances 2. Disinfection of the2. Mixture of vitamins and/or vitamin wound derivatives, metal ions,surfactants 4 1. Disinfection of the 1. Mixture of vitamins and/orvitamin wound derivatives, metal ions, surfactants 2. Conditioning ofthe 2. Urea, aloe vera wound surface

In addition, in accordance with the invention, it is intended that sucha kit be used for external, non-systemic, topical care and/or treatmentof wounds to human or animal bodies, whereby various components of thekit are used during various phases of the wound.

In deviating from this approach, it may naturally also be intended thata composition, particularly a pad, a protective dressing and/or adressing is provided which is configured such that the substances orcomplexes of substances contained therein are appropriate to the woundin each phase of the healing process. The background for this approachis that there are wounds which are simultaneously in different phases ofthe healing process at different points on the wound. It is naturallyadvantageous to be able to meet the needs of all of these points withonly one product.

In addition, the solubility characteristics of individual substances orcomplexes of substances may be adjusted such that they dissolve atdifferent points in time (i.e. in different phases of the healingprocess) and are released into the wound. For this, for example,different sizes of the particles may be determined, i.e. a largerparticle sizes may be used for substances or complexes of substancesthat are to be released at a later period, and smaller particle sizesmay be used for substances or complexes of substances that are to bereleased at an earlier period (sustained-release effect).

Alternatively, the respective substances or complexes of substances maybe arrayed in degradable capsules having different degradable constants,thus releasing their contents to the wound in the appropriate phases. Inthis manner, the sustained-release effect can also be obtained.

In summary, it can be said that new standards in the treatment of woundscan be established through these means of wound phase appropriate care.

ILLUSTRATIONS AND EXAMPLES

The present invention will be explained in greater detail through thepresentation and discussion of the following illustrations. It should benoted thereby that the illustrations and examples have only thedescribed character, and in no manner are intended to limit theinvention.

Example 1 Composition of a Nutrient Composition without Proteins

Component Quantity Isoleucine 2.5 g Leucine 3.7 g Lysine-HCL 4.125 gMethionine 2.15 g Phenylalanine 2.55 g Threonine 2.2 g Tryptophan 1 gValine 3.1 g Arginine 6 g Histidine 1.5 g Glycine 7 g Alanine 7.5 gProline 7.5 g Malic acid 3.065 g Glucose 1H₂O 220 g Sodium chloride1.169 g Potassium chloride 2.238 g Calcium chloride 2H₂O 0.368 gMagnesium chloride 6H₂O 0.509 g Zinc chloride 0.0055 g Glycerol-1(2)-4.592 g dihydrogen phosphate - mixed with disodium salts Total 282.78 g

The composition meets the needs of a fully balanced parenteral dieteticcomposition. It contains, in the amounts listed, approximately 60% ofthe daily requirements of a man weighing 80 kg (176 lbs) based on therecommended daily dosage of the DGE (Deutsche Gesellschaft fürErnährungsmedizin [: German Society for Nutritional Medicine]). In theuse with a dressing for wounds, this corresponds to a topical overdose.This overdosing, however, does not serve the purpose of correcting ageneral insufficiency in the nutritional situation of a patient orprevention of a systemic sepsis, as a systemic effect is neitherintended nor desired, as is mentioned above.

Example 2 Composition of a Nutrient Composition in Accordance with theInvention, without Proteins and without Carbohydrate Sources

Isoleucine: 2.5 g, Leucine: 3.7 g, Lysine-HCL: 4.125 g (containing 3.3 gL-Lysine), Methionine: 2.15 g, Phenylalanine: 2.55 g, Threonine: 2.2 g,Tryptophan: 1 g, Valine: 3.1 g, Arginine: 6 g, Histidine: 1.5 g,Glycine: 7 g, Alanine: 7.5 g, Proline: 7.5 g, Malic acid: 3.065 g,Sodium chloride: 1.169 g, Potassium chloride: 2.238 g, Calcium chloride2H₂O: 0.368 g, Magnesium chloride 6H₂O: 0.509 g, Zinc chloride: 0.0055g, Glycerol-1(2)-dihydrogen phosphate—mixed with disodium salts 5H₂O(40/60 G/G): 4.592 g, (in mmol/l: Na⁺ 50, K⁺ 30, Ca²⁺ 2.5, Mg²⁺ 2.5,Zn²⁺ 0.04, Cl⁻ 100.11, Glycerophosphate 15).

The composition meets the needs of a fully balanced parenteral dieteticcomposition with the absence of glucose. This may be applied in the caseof highly infected wounds in order to prevent a supply of carbohydratesto the infectious bacteria.

Example 3 Composition of an Additional Nutrient Composition inAccordance with the Invention

Glucose syrup, maltodextrin, vegetable oil, soy protein isolate, milkprotein, inulin, guar gum, glucose, soy fiber, emulsifier: soy lecithin,magnesium carbonate, calcium orthophosphate, potassium chloride, cholinehydrogen tartrate, calcium carbonate, vitamin mixture (vitamin C,niacin, vitamin E, pantothenate, vitamin B2, vitamin B6, vitamin B1,vitamin A, folic acid, vitamin K, biotin, vitamin D3, vitamin B12),sodium citrate, taurine, iron lactate, L-carnitine, zinc oxide,potassium fluoride, manganese sulfate, copper sulfate, potassium iodate,chromium chloride.

Said composition contains the following nutrients quantities:

Component Ø content per 100 g powder Energy 1821 kJ/433 kcal Protein(13% energy) 13.8 g Carbohydrates (56% E.) 60 g Roughage 6.2 g Fat (30%energy) 14.6 g saturated fatty acids 5.2 g simple unsaturated fattyacids 6.4 g complex unsaturated fatty acids 3 g Sodium 260 mg Potassium435 mg Calcium 260 mg Magnesium 70 mg Phosphor 176 mg Chloride 385 mgIron 4.8 mg Zinc 4.7 mg Copper 435 μg Iodine 45 μg Chromium 20 μgFluorine 0.4 mg Manganese 0.6 mg Molybdenum 22 μg Selenium 12.5 μgVitamin A 260 μg Vitamin D 3.1 μg Vitamin E 9.5 mg Vitamin K 35 μgVitamin B1 0.45 mg Vitamin B2 0.58 mg Vitamin B6 0.45 mg Vitamin B12 1.1μg Vitamin C 60 mg Niacin 5.9 mg Folic acid 70 μg Pantothenic acid 2.6mg Biotin 16 μg Choline 77 mg Taurine 24 mg L-carnitine 6.5 mg Inositol18 mg

The composition meets the needs of a fully balanced enteral dieteticcomposition. In the quantities listed it corresponds to approximately30% of the daily requirements of an 80 kg (176 lbs.) man, in accordancewith the recommended daily dosage of the DGE (Deutsche Gesellschaft fürErnährungsmedizin [: German Society for Nutritional Medicine]). In theuse with a dressing for wounds, this corresponds to a topical overdose.This overdosing, however, does not serve the purpose of correcting ageneral insufficiency in the nutritional situation of a patient orprevention of a systemic sepsis, as a systemic effect is neitherintended nor desired, as is mentioned above.

As the case may be, it may be intended that the carbohydrate portion(particularly glucose, but also, as the case may be, maltose,maltodextrin, isomaltose or starch) be omitted, in order to prevent asupply of carbohydrates to infectious bacteria in the case of a highlyinfected wound. In addition, it may be intended that roughage such asinulin or soy fiber, emulsifiers such as monoglyceride or diglyceride orsoy lecithin and/or thickening agents such as guar gum be omitted.

Example 4 Composition of Various Disinfecting Compositions in Accordancewith the Invention Containing at Least One Vitamin or VitaminDerivative, a Metal Ion and a Detergent in 50 μg Distilled Water

Vitamin or derivative Metal ion Detergent 100 mM vitamin C 10 mM FeCl₃0.5% SDS  50 mM Vitamin E 100 mM vitamin C 10 mM ZnCl₂   2% TritonX-100 50 mM Vitamin E 0.2% Tween 20

Example 5 Composition in Accordance with the Invention ContainingNon-Pathogens, Lactic Acid Producing Micro-Organisms as AcidifyingAgents

A composition containing the following components:

Component Quantity Lactobacillus acidophilus 6.3% by mass Lactococcuslactis 2.1% by mass Bifidobacterium Longum 2.1% by mass Lactobacillusrhamnosus 1.4% by mass Bifidobacterium breve 1.4% by massBifidobacterium bifidum 0.7% by mass Ascorbic acid 1% by mass Potatostarch as carrier Ad. 100% by mass

The micro-organisms specified are available in freeze-dried form and areactivated on contact with the wound through heat and moisture.

The composition is composed in such a manner that 2 grams of saidcontains at least 5×10⁸ of the respective bacteria.

Example 6 Composition in Accordance with the Invention ContainingNon-Pathogens, Lactic Acid Producing Micro-Organisms as AcidifyingAgents, Such as Prebiotics

Added to 2 g of the composition in example 5 are 5 g of a mixture ofinulin (65% by mass), oligofructose (20% by mass) and Jerusalemartichoke juice powder (15% by mass).

Example 7 Production of a Dressing Containing SAP which Contains aComposition in Accordance with the Invention

A composition in accordance with any of the examples 1-6 is compressedtogether with cellulose fibers. The following quantities per 100 gcellulose fibers are used thereby:

Corresponds to portion of Composition of example Quantity systemic dailydosage of 1 (nutritive) 100 g 21% 2 (nutritive)  22 g 21% 3 (nutritive)100 g 30% 4 (disinfecting)  50 μg water n/a 100 mM vitamin C  50 mMvitamin E  10 mM FeCl₃ 0.5% SDS 5 (acidifying)  2 g 100%  6 (proteasesinhibiting)  7 g 100%  1 + 4 See above 21% (nutritive and disinfecting,suited to wound phase 3)

The cellulose fibers are then replaced in a process with 50% by masssuper-absorbent polymers (co-polymer of acrylic acid and sodiumacrylates), as is described in the DE19750890, the contents of thedisclosure of which shall be added in full to this writing, andprocessed in an air-laid of the dimensions 20×10 cm. Subsequently, thisair-laid shall be covered on both sides with a cellulose pad, and packedin a sheath of polypropylene, having pores ranging in size between 0.1mm and 1.0 mm. The sheath shall have an ultra-sound seal on its edges.

Example 8 Production of a Dressing Made of PU Foam, Containing aComposition in Accordance with the Invention

A composition in accordance with any of the examples 1-6 is dissolved in200 ml distilled water, in the same quantities as those in example 7.Subsequently, a 20×20×0.3 cm pad of PU foam shall be impregnated withthis solution, and dried.

Example 9 Production of a Dressing Containing a QAV

A composition in accordance with any of the examples 1-6 as well as 20mg benzalkonium chloride is dissolved in 200 mg distilled water, in thesame quantities as used in example 7. Subsequently, a 20×20×0.3 cm padof PU foam shall be impregnated with this solution, and dried.

FIG. 1: Absorption of exudation dressing which is for the most part dry,or, respectively, a moistened dressing containing super-absorbentpolymers.

FIG. 1A shows the absorption of exudate in a, for the most part, dry,absorbent dressing containing super-absorbent polymers, as is describedin the DE10059439 as well as the WO03094813 by the applicant of thepresent invention. A dressing of this type has, particularly in theinitial phase, an enormous capacity for absorption, which is representedby the hyperbolic curve shown therein. Due to the bondingcharacteristics of the super-absorbent polymers in regard to proteins,particularly matrix proteases as well as bivalent cations, these aredischarged quickly from the wound, thereby promoting the healingprocess. This is of particular advantage when the dressings are to bechanged frequently. Is shall then be ensured that at the point in timewhen the dressing is changed, the saturation capacity of the dressing(and thereby the maximal bonding capacity of matrix proteases andbivalent cations) has been reached.

FIG. 1B in contrast shows the exudate absorption of a dressingcontaining super-absorbent polymers, moistened with Ringer's solution.In this case, a cleansing body is applied to the wound, whereby in acyclical process Ringer's solution is released into the wound and inturn absorbed from said, thereby cleansing the wound. A dressing of thissort does not exhibit a net absorption of fluid in this manner. Duringthe cleansing process, however, the wound is successively washed and theexudate and its contents, particularly matrix proteases and bivalentcations, are absorbed by the dressing, where they are restrained by thesuper-absorbent polymers present therein. Due to the passive cleansingprinciple, this is however a very length process, which requires alonger period of time than is required for the dressing to be applied tothe wound. It can therefore be the result that the dressing already ischanged before it has reached its maximal saturation point.

1. A composition containing at least one nutrient, at least onedisinfecting or decontaminating and/or at least one proteases inhibitingsubstance and/or complex of substances for external care and/ortreatment of wounds to a human or animal body, where the composition isincorporated in an absorbent dressing containing a foam pad, anair-laid, a carboxymethyl cellulose pad, and alginate pad and/or a padcontaining super-absorbent particles.
 2. (canceled)
 3. A composition inaccordance with claim 1, characterized in that the dosage form of atleast one substance or complex of substances is selected such that itcomprises solely a topical effect.
 4. A composition in accordance withclaim 1, characterized in that at least one substance or of substancesis available in a water soluble form.
 5. A composition in accordancewith claim 1, characterized in that at least one substance or complex ofsubstances is available in a form whereby upon direct or indirectcontact of said substance to the wound a migration of said substance tothe wound is enabled.
 6. A composition in accordance with claim 1,characterized in that at least one substance or complex of substances isincorporated in a water soluble matrix.
 7. (canceled)
 8. A compositionin accordance with claim 1, characterized in that at least one substanceor complex of substances is incorporated in a protective dressing.9.-12. (canceled)
 13. A composition in accordance with claim 1,characterized in that at least one substance be made available in aprepared form through a process selected from the group containing:freeze-drying, lyophilization, spray drying, roller drying and/or vacuumevaporation.
 14. A composition in accordance with claim 1, characterizedin that the composition or the components of said substance areavailable in a sterilized form.
 15. A composition in accordance withclaim 1, characterized in that for at least one of the disinfectingcomplexes of substances, said substance consists of a composition of atleast one vitamin or vitamin derivative, a metal ion and a cleansingagent.
 16. A composition in accordance with claim 1, characterized inthat the at least one of the disinfecting substances or complexes ofsubstances, said consists of a BUS (bacteriocin-like inhibitorysubstance).
 17. A composition in accordance with claim 1, characterizedin that the at least one of the disinfecting substances or complexes ofsubstances consists of coated magnetic particles.
 18. A composition inaccordance with claim 1, characterized in that the at least one of thenutritive substances is a composition containing at least the componentsof an enteral and/or parenteral dietetic composition.
 19. A compositionin accordance with claim 1, characterized in that, for the at least oneof the nutritive substances or complexes of substances, at least oneactive element is selected from the group containing insulin,recombinant insulin, proinsulin, an insulin-like growth factor (IGF), aninsulin mimetic and/or a diabetic specific non-glucose or non-sucroseenergy source.
 20. A composition in accordance with claim 1,characterized in that, for the at least one proteases inhibitingsubstances and/or complexes of substances, at least one active elementis selected from the group containing proteases inhibitors,super-absorbent polymers, chelators for bivalent cations, collagen,coated magnetic particles, acids, buffer, non-pathogenic acid producingmicro-organisms, probiotics, and/or symbiotics.
 21. A composition inaccordance with claim 1, characterized in that the compositionfurthermore contains one or more substances selected from the groupcontaining orthomolecular nutrients, nutraceuticals, phytochemicals,growth factors, petroleum based blistering ointments, methylxanthine,mineralocorticoids, tannins, tacrolimus, pimecrolimus, polidocanol,surfactants, ATP, urea, necrolytes, sympathomimetics,parasympatholytics, activated carbon, octenidine, polyhexanide,homeopathic remedies, Q10, lysine, pectin, agar, aloe vera,hemostyptics, formic acid, fruit acid, succinic acid, maggot saliva,spider web protein, collagen, glycerin, biofilm damaging substances,triacetin, thickening agents, karaja, zinc oxide, odor inhibitingsubstances, gelling agents, exudation promoting substances, and/orswelling reducing substances.
 22. A composition in accordance with claim1 characterized in that for the vitamins, one or more vitamins areselected from the group containing Vitamin B12, vitamin D, vitamin C,vitamin B1, vitamin B2, vitamin B6, niacin, and/or folk acid.
 23. Adressing containing a foam pad and/or super-absorbent particles,characterized in that said contains a composition in accordance withclaim
 1. 24. (canceled)
 25. (canceled)